- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01213420
Aruba Aloe Formula F-BC-096 in the Treatment of Split Thickness Donor Site After Wound Closure
A Prospective, Randomized Controlled, Double Blinded, Clinical Multicentre Trial of the Aruba Aloe Formula F-BC-096 in the Treatment of Split Thickness Donor Sites After Wound Closure
This study is a prospective, randomized controlled, double blinded, study in a multi centre setting. Three burn centres will include 60 patients in total.
If suited for the study (= two equal donor sites) and after informed consent, patients will be observed starting the day of skin prelevation.
A coded file will be made for each patient and these files should contain the localization of both donor sites, their depth as determined by the setting of the dermatome and the treatment. Treatment for both donor sites will always be equal.
The date of wound healing of each donor site, which may only differ by a maximum of five days, will be noted. Digital photographs of the healed donor sites will be taken and the scars will be evaluated by the local researchers using the Adapted Vancouver Scar Scale prior to the start of hydration.
From that moment on one donor site will be treated with Aruba Aloe formula F-BC-096 while one of the control products will be applied to the second site. Per group of five patients per centre a different control product will be applied to the second donor site. The tubes containing these products will be colour and numerical coded. Nor the treating personnel, nor the patients will be informed which colour tubes contain the control products and which contain the Aruba Aloe formula F-BC-096. If it is necessary to apply pressure garments for one donor site, the garments will be applied for both sites.
Follow-Ups will be performed on one, three and six months after wound closure. Objective methods will be used during these follow-ups to evaluate elasticity and colour of the scar, this by using the Dermalab, the Cutometer®, the Derma Spectrometer and the Mexameter®. The evaporation, permeability and hydration of the scar will be measured by using the Tewameter® and the Corneometer®. The Reviscometer® will measure the direction of collagen and elastin. The Adapted Vancouver Scar Scale will be used as a subjective method. Also different scales for evaluation of donor site pain, patient satisfaction, product comfort, itching etc. have to be completed by the patient.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Antwerp, Belgium
- Hospital Network Antwerp
-
Ghent, Belgium
- University Hospital Ghent
-
Neder-Over-Heembeek, Belgium
- Military Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have two similar donor sites regarding location, depth and wound treatment.
- Healing time of both donor sites may differ by 5 days maximum.
- Patient compliance with therapy in relation to the protocol is necessary. In case of paediatric patients this depends on the collaboration of the parents.
- For the two donor sites to be compared, the entire after-treatment concerning pressure garments or eventual silicone sheets must be equal for both donor sites. Pressure garments and/or silicone sheets are used only in case of burn wounds within the same location.
- Patients must be available for regular and necessary follow-up (up to 6 months post healing).
- Possibility to finish all measurements during follow-up visits.
- Written authorisation of the patient, family or parents is required.
Exclusion Criteria:
- Donor sites are not similar (not identical in: depth, wound treatment, healing time).
- The patient has a known allergy to Aloe Vera and/or to preservatives in cosmetic products.
- The patient is not able to follow the complete treatment schedule.
- The patient has any condition(s) that seriously compromises the patient's ability to complete this study.
- The occurrence of a traumatic wound over the healed donor site (e.g. abrasion, skin tear, …)
- The patient wishes to terminate the study.
- No informed consent before start of the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aloë Vera FORMULA F-BC-096
|
3 applications per day during 6 months.
|
Active Comparator: Aloë Vera FORMULA F-BC-096 with modified preservative
|
3 applications per day during 6 months
|
Active Comparator: Eucerin Calming cream
|
3 applications per day during 6 months
|
Active Comparator: Nivea Cream
|
3 applications per day during 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
improvement in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators
Time Frame: after 6 months of scar hydration
|
|
after 6 months of scar hydration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
improvement of overall scar quality in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators:
Time Frame: after 6 months of scar hydration
|
after 6 months of scar hydration
|
improvement of overall product satisfaction in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators
Time Frame: after 6 months of scar hydration
|
after 6 months of scar hydration
|
improvement of scar colour in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators
Time Frame: after 6 months of scar hydration
|
after 6 months of scar hydration
|
improvement of scar elasticity in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators
Time Frame: after 6 months of scar hydration
|
after 6 months of scar hydration
|
improvement of collagen and elastin direction in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators
Time Frame: after 6 months of scar hydration
|
after 6 months of scar hydration
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stan Monstrey, MD, PhD, University Hospital Ghent, Belgium
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009/567
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Wounds
-
Centre Hospitalier Universitaire de NīmesCompleted
-
3MWithdrawn
-
University of WashingtonU.S. Department of Justice; Arnold Ventures; City of SeattleCompleted
-
Smith & Nephew, Inc.Not yet recruitingChronic Wounds | Acute WoundsCanada
-
SerenaGroup, Inc.MDM Wound Ventures, LLCCompletedChronic Wounds | Acute WoundsUnited States
-
University of PittsburghThe Pittsburgh Foundation; Hillman Foundation; RK Mellon FoundationCompletedSkin Injury Due to Violence | Gunshot Wound, ContactUnited States
-
SerenaGroup, Inc.Anacapa Technologies IncCompleted
-
Medical University of South CarolinaCompletedNeedlestick InjuriesUnited States
-
Hospital Universiti Sains MalaysiaActive, not recruiting
-
Ohio State UniversityCompleted
Clinical Trials on Aloë Vera FORMULA F-BC-096 for scar hydration
-
University Hospital, GhentWithdrawnHydration of ScarsBelgium